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Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following Endoscopic Sinus Surgery

NCT00705354 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-04-13

No results posted yet for this study

Summary

This study will compare the incidence of post-op infection after sinus surgery using conventional post-op oral antibiotics to the incidence of infection after sinus surgery when a bio-resorbable antibiotic soaked nasal sponge is used in the nasal cavity in lieu of post-op oral antibiotics. The nasal sponge is a routine nasal dressing used after sinus surgery and will therefore be placed in all patients.

Conditions

  • Sinusitis
  • Chronic Sinusitis

Interventions

DRUG

Bacitracin

Nasopore sponge soaked with Bacitracin, placed in middle meatus of the nose. No post-op oral antibiotics

PROCEDURE

Nasopore sponge soaked with saline

Nasopore sponge soaked with saline placed during surgery and will receive routine oral antibiotics post-operatively

Sponsors & Collaborators

  • Lahey Clinic

    lead OTHER

Principal Investigators

  • Peter J. Catalano, M.D. · Lahey Clinic, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00705354 on ClinicalTrials.gov